This invention relates generally to diagnostic assays, and more particularly, to a method and apparatus for configuring both data and assays (e.g., micro-system platforms) on a single compact disk.
Prior to the present invention, it has been known to provide clinical assays/micro-system platforms on disks capable of being driven in a manner similar to CDs or DVDs. Generally speaking, in such systems, the disk, which comprises of a plurality of assays, each having a number of chambers and microchannels containing the components necessary for conducting the given test/analysis, is rotated at predetermined speeds. As a result of the centrifugal force generated by the rotation of the disk, the chemicals, fluids, samples, etc. move through the chambers/microchannels of the given assay, and a result is generated.
U.S. Pat. No. 6,063,589, which is herein incorporated by reference, illustrates an example of a micro-system platform formed on a CD type disk. For example, referring to FIGS. 1 and 2 thereof, the assay array 12 includes a sample entry port 201 which is connected with an array of metering capillaries 202. The entry port is coupled to an overflow capillary 203, which is connected to an overflow chamber 205. The metering capillaries are also coupled to a fluid chamber 204. Each of the overflow and fluid chamber is coupled with an air channel, for example, channel 211. The assay further includes a holding chamber 207 which is connected to the fluid chamber 204 via capillary 206. Finally, the assay includes a read chamber 210 coupled to the holding chamber 207 as valve 213.
As explained in detail in the ""589 patent, by various means, e.g., centrifugal force, a portion of a sample input via the sample entry port is moved through the various capillaries, and possibly mixed with reagents already disposed with the chambers, in accordance with the given assay being conducted, so as to perform the desired test/analysis associated with the given assay. In one example, the result of the assay is determined based on the presence or absence of an analyte, which if present will be contained in the read chamber 210.
U.S. Pat. No. 6,030,581, which is also incorporated herein by reference, illustrates another example of a micro-system platform formed utilizing a disk type format. Referring to FIG. 1 thereof, the micro-system platform contains two sectors: an assay sector 11 and a software sector 12. The assay sector 11, which operates on a given sample, can be formed of one of more of the components illustrated in FIG. 2A. Examples of particular assays are set forth in FIGS. 2B and 4. The software sector 12 contains instructions for controlling the rotation regimen of the disk associated with the given assay contained in the assay sector 11.
Notwithstanding the foregoing known micro-system platforms formed utilizing disk formats, problems remain. For example, known micro-system platforms do not provide for the recordation of the results of the analysis as the analysis pertains to a particular patient, or for recordation of a test log. In addition, the design of known micro-platforms inherently limit the amount of disk space available for storing control commands and the amount of disk space available for assays. Further, known micro-system platforms do not provide for retrieval of control information in an optimum manner, thereby causing a decrease in the overall operating speed of the micro-system platform.
Accordingly, there remains a need for providing a micro-system platform capable of storing data associated with patient results and records, as well as a test log associated with performance of the actual test. In addition, there is a need for a micro-system platform which optimizes the space available for data storage and assays, and which optimizes the reading and writing of such data so as to maximize the overall operating speed of the system.
It is the object of the present invention to correct the foregoing deficiencies in the prior art.
In general, the present invention relates to a micro-system platform that provides for the recordation of patient information, test results associated with individual patients, test log information and control information associated with the particular assay to be conducted. In addition, the design of the micro-platform of the present invention is such that it optimizes both the amount of data that can be recorded/stored and the number of assays to be accommodated on a single disk, as well as the time associated with reading and writing information/data.
In a first exemplary embodiment, the present invention relates to an apparatus for performing an assay, where the apparatus comprises a micro-system platform, a CD-ROM device and an information processor. The CD-ROM device is under control of the information processor and is capable of reading and writing data to the micro-system platform. The micro-system platform comprises a first section for storing data in a continuous circular data band, which is disposed in an inner portion of the micro-system platform, and a second section including at least one assay, which is formed in an outer portion of the micro-system platform. During operation, the CD-ROM device retrieves and stores data relating to the performance of the assay in the data band. The information processor is operative for controlling the CD-ROM device in accordance with the data retrieved from the data band so as to conduct the assay, and for analyzing the results of the assay.
The present invention also relates to a method of conducting an assay utilizing an apparatus comprising a micro-system platform, a CD-ROM device and an information processor, where the micro-system platform comprises a first section for storing data in a continuous circular data band disposed in an inner portion of the micro-system platform, and a second section including at least one assay formed in an outer portion of said micro-system platform. The method comprises the steps of retrieving data related to the performance of the assay from the circular data band, controlling the CR-ROM device in accordance with the data retrieved from the circular data band so as to manipulate the micro-system platform as required to conduct the assay, analyzing the results of the assay, and storing data indicative of the results of the assay in the circular data band.
As described in further detail below, the present invention provides significant advantages over the prior art. Most importantly, the micro-system platform of the present invention is capable of storing data associated with patient results and records, as well as a test log associated with performance of the actual assay on the given micro-system platform. As a result, all information pertaining to the performance and results of a given test is stored within a single medium (i.e., the micro-system platform), and these results can be re-examined in future years without any degradation or loss of relevant information. Thus, the present invention improves the integrity of maintaining such test results over an extended period of time as all pertinent information is contained on the micro-system platform.
Another advantage provided by the micro-system platform of the present invention is that it optimizes the space available for data storage and assays for a given platform size, as well as optimizes the reading and writing of data to the micro-system platform so as to maximize the overall operating speed of the system. In particular, as explained below, by forming the information/data band as a single continuous track, the retrieval/access time associated with retrieving or storing data is minimized, thereby allowing for faster overall operation.
An additional advantage of the present invention is that it allows the CDROM software to automatically start reading from the inner most track, and continue reading in a contiguous manner, thereby allowing the present invention to take advantage of all the existing technology for CD type drives.
Additional advantages of the present invention will become apparent to those skilled in the art from the following detailed description of exemplary embodiments of the present invention.
The invention itself, together with further objects and advantages, can be better understood by reference to the following detailed description and the accompanying drawings.